Deviations and Delays

They may have seemed harmless at first, but these ideas took a big bite.
Jul 01, 2008

Double strength gets double delays



"My company had developed a double-strength version of an existing oral liquid OTC product," explains our GMP Agent-in-Place. "When the label came to me for review, I merely noted that we must state on the label that it does not meet USP standards, because at that time, USP defined the strength of the product.

"What an uproar that caused! The product would clearly be at a competitive disadvantage if we had to say 'Not USP' on the label! So we petitioned USP to change the monograph to list the limits as a percent of label claim, rather than as an absolute therapeutic target. About a year later, we were able to launch the new double-strength version successfully."

A deviation by any other name

"During a typical FDA inspection, the investigator asked for a list of our deviations," says our GMP Agent-in-Place. "We provided the list, but we didn't include stability alerts because they weren't deviations, nor environmental monitoring excursion notices, planned process modifications (a planned deviation?), complaint reports, out of tolerance reports, out of specification reports, overdue calibration report, overdue environmental monitoring reports, adverse event reports, audit findings and corrective action reports, media failure investigation reports, validation failures, computer incident reports, maintenance overdue reports, raw material failure alerts, overdue training reports, and so forth.

"This worked for one inspection, but all heck broke loose at a later inspection when an FDA investigator came across some of the other items and noted that we had different standards of root-cause analysis, investigation, and CAPA for these items. We ended up merging all the systems into one, well thought-out, compliant system, but it took a while!"

Out of my site, out of my mind

"The new owners of our division were smart guys. All our sites made substantially the same products, so they reorganized production and moved it to the cheapest site," explains our GMP Agent-in-Place. "So they fired half the staff based on this business model and made additional plans to discontinue manufacture of several products and to reduce production levels in general due to oversupply in the marketplace.

"But the products were never dropped, and movement of production took longer than they thought, and the market had a turnaround so demand increased. The production areas that were planned to be closed off were not closed. And the staff to run these areas still were needed, including maintenance, production operators to run equipment, calibration staff, QA release, QC lab support, environmental monitoring staff and so forth. To this day, we are still rehiring people."

Training through osmosis?

"Flash back 30 years," says our GMP Agent-in-Place. "Not long after the modern GMPs were issued, our company developed extensive training modules for these new regulations, 30-60 minutes for each GMP sub-part, to meet the GMP training requirement.

"But employees soon grew tired of them, and some would sleep in the back of the room. The sign-in sheet was the only documentation of training, so other employees would ask their colleague to sign them in for the training. It was a large facility and the trainers didn't know all the employees."

Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law in action, please send it to Control at
We won't use any names, but if we do use your tale of disaster, courage, or just plain weirdness, Control will send you a coveted Pharmaceutical Technology t-shirt.